NCT01609959

Brief Summary

The purpose of this study is to compare blood pressure lowering effect of azilsartan with that of valsartan in Japanese patients with hypertension who have already taken normal-dose angiotensin II receptor blockers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 30, 2013

Status Verified

October 1, 2013

Enrollment Period

1.3 years

First QC Date

May 30, 2012

Last Update Submit

October 28, 2013

Conditions

Hypertension

Keywords

HypertensionAngiotensin II Receptor BlockerAzilsartanValsartan

Outcome Measures

Primary Outcomes (1)

  • Change in Office Blood Pressure

    Change in blood pressure measured at a clinic

    Baseline and every 2 weeks (up to 12 weeks)

Secondary Outcomes (5)

  • Change in Home Blood Pressure

    Baseline and every 2 weeks (up to 12 weeks)

  • Change in Renal Function

    Baseline and 12 weeks

  • Change in Fasting Triglyceride

    Baseline and 12 weeks

  • Change in Glycemic Control

    Baseline and 12 weeks

  • Change in Plasma Aldosterone Concentration

    Baseline and 12 weeks

Study Arms (2)

Azilsartan group

ACTIVE COMPARATOR
Drug: Azilsartan

Valsartan group

ACTIVE COMPARATOR
Drug: Valsartan

Interventions

AzilsartanDRUG

Azilsartan 20 mg or 40 mg (if blood pressure does not reach the target after 6 weeks) per day for 12 weeks

Azilsartan group
ValsartanDRUG

Valsartan 160 mg per day

Valsartan group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertensive patients treated with normal-dose angiotensin II receptor blockers (ARBs) in Japan
  • Normal-dose ARBs in Japan are defined as follows: losartan potassium 50 mg, candesartan cilexetil 8 mg, valsartan 80 mg, telmisartan 40 mg, olmesartan medoxomil 20 mg, or irbesartan 100mg per day.

You may not qualify if:

  • Hypersensitivity for azilsartan and valsartan
  • Pregnant female
  • History of azilsartan use within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Department of Nara Medical University

Kashihara, Nara, 634-8522, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

azilsartanValsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Yoshihiko Saito, MD, PhD

    First Department of Internal Medicine, Nara Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 30, 2012

First Posted

June 1, 2012

Study Start

June 1, 2012

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

October 30, 2013

Record last verified: 2013-10

Locations

JP(1)